Results of the Afatinib Expanded Access Program (EAP): Efficacy and Safety

which were diarrhea (5.4%/0%), rash (2.7%/20.0%), fatigue (8.1%/0%), headache (5.4%/5.7%), acne/dermatitis acneiform (0%/5.7%) and hypophosphatemia (0%/ 5.7%). Two pts on A+C (5.7%) had G4 DRAEs (hypomagnesaemia, 1 pt; rash, 1 pt). There were no G5 DRAEs. PK parameters, which did not identify a clinically relevant effect of A on exposure to C, or vice versa, will be presented. Conclusions: Sequential EGFR blockade with A then A+C had an acceptable safety profile and was effective, achieving responses and DC in pts with EGFR mutation-positive NSCLC with acquired resistance to E/G. Despite a low ORR, sequential use of A+C was associated with a median PFS of 2.7 months after progression on A, and may offer an alternate, more tolerable approach for treating such pts. Author Disclosure: L. Horn: E. Research Grant; Astellas. F. Honoraria; Boehringer Ingelheim. G. Consultant; Bayer (uncompensated). I. Travel Expenses; Boehringer Ingelheim. K. Advisory Board; Bristol Myers Squibb, Clovis, Helix Bio, PUMA (uncompensated). S. Gettinger: G. Consultant; BMS, Ariad. R. Camidge: E. Research Grant; Ariad. F. Honoraria; Ariad, Boehringer Ingelheim, Synta, Array Biopharma, Pfizer. K. Advisory Board; Servier, Eli Lilly, Genentech/Roche, Astex, Ariad, ImmunoGen, Clarient, Excelixis, IndiPharm, Astellas, Boehringer Ingelheim, Chugai, Clovis, Array Biopharma, AstraZeneca, Aveo, Novartis, Synta. E. Smit: None. Y. Janjigian: E. Research Grant; Boehringer Ingelheim, Bayer. K. Advisory Board; Lilly. W. Pao: A. Employee; Roche Pharmaceuticals (commencing May 2014). E. Research Grant; Enzon, Xcovery, AstraZeneca, Symphogen, Clovis Oncology, Bristol-Myers Squibb. G. Consultant; MolecularMD, AstraZeneca, Bristol-Myers Squibb, Symphony Evolution, Clovis Oncology, Exelixis, Clarient, Champions, Clarient (MDOutlook), WebMd, Other: Academic talks (NCCN, IASLC, UALC, ASCO, AACR). Q. Patent/License Fee/Copyright; joint holder of licensed rights to EGFR T790M testing. Licensed by MSKCC to Molecular MD. D. Schnell: A. Employee; Boehringer Ingelheim. B. Wang: A. Employee; Boehringer Ingelheim. V. Chand: A. Employee; Boehringer Ingelheim Pharm. Inc. D. Employment Other; Boehringer Ingelheim Pharm. Inc. I. Travel Expenses; Boehringer Ingelheim Pharm. Inc. H. Groen: None.